SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial

Obesity Clinical Trial

— SELECT-LIFE  

Official title:

SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972721
• Other study ID #: EX9536-4750
• Secondary ID: U1111-1255-5644
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: November 30, 2033

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.

SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.

SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.

When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.

Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.

The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3400
• Est. completion date: November 30, 2033
• Est. primary completion date: April 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.

• Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

Exclusion criteria:

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• No treatment given
The study is non-interventional with no study-specific treatment during the study and the patients will be treated as per Treating Physician's and patient's own discretion.

Locations

Country	Name	City	State
Algeria	Master Centre for Algeria	Algiers
Argentina	Master Centre for Argentina	Prov. De Buenos Aires
Australia	Master Centre for Australia	Baulkham Hills	New South Wales
Brazil	AngioCor Blumenau	Blumenau	Santa Catarina
Brazil	Hospital do Coração do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	Núcleo de Pesquisa Clínica S/S	Curitiba	Parana
Brazil	Hospital São Vicente de Paulo	Passo Fundo	Rio Grande Do Sul
Brazil	Instituto Brasil de Pesquisa Clinica	Rio de Janeiro
Brazil	Cárdio Pulmonar da Bahia	Salvador	Bahia
Brazil	CIP Centro Integrado de Pesquisas do Hospital de Base	São José do Rio Preto	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Brazil	Departamento de Gastroenterologia - HCFMUSP	São Paulo	Sao Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	Sao Paulo
Brazil	Instituto do Coração - HCFMUSP	São Paulo	Sao Paulo
Brazil	Master Centre for Brazil	Säo Paulo	Sao Paulo
Brazil	Eurolatino Medical Research Center	Uberlândia	Minas Gerais
Canada	Master Centre for Canada	Mississauga	Ontario
Croatia	Novo Nordisk Croatia Ltd.	Zagreb
Denmark	Master Centre for Denmark	Copenhagen S
Finland	Master Centre for Finland	Espoo
Germany	Master Centre for Germany PMS	Mainz
Greece	Master Centre for Greece	Vouliagment
India	Master centre for India	Bangalore
Ireland	Master Centre for Ireland	Dublin 9
Italy	Master Centre for Italy	Rome
Japan	Master Centre for Japan	Tokyo
Latvia	MAster Centre for Latvia	Marupes
Malaysia	Master Centre for Malaysia	Selangor Darul Ehsan
Netherlands	Master Centre Netherlands	Alphen A/d Rijn
Norway	Master Centre for Norway	Rud
South Africa	Master Centre for South Africa	Sandton	Gauteng
Sweden	Master Centre for Sweden	Malmö
Taiwan	Master Centre for Tawain	Taipei
Thailand	Master Centre for Thailand	Bangkok
United Kingdom	Master Centre for United Kingdom	Crawley
United States	Master Centre for USA	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Australia,  Brazil,  Canada,  Croatia,  Denmark,  Finland,  Germany,  Greece,  India,  Ireland,  Italy,  Japan,  Latvia,  Malaysia,  Netherlands,  Norway,  South Africa,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to all-cause death	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of non-fatal myocardial infarction	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of non-fatal stroke	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to diagnosis of type 2 diabetes	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of any type of cancer	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of a composite of obesity related cancer defined by WHO	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of knee replacement	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of bariatric surgery	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of anti-obesity medical treatment	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Time to first occurrence of use of continuous positive airways pressure (CPAP) device	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Total number of myocardial infarctions	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Total number of strokes	Measured in months	From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary	Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)	Measured in Kg	From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary	Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)	EQ-5D-5L score The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.	From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary	Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)	Days	From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)